Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a Senior Biochemist for the Technical Operations to support the manufacture of immunochemistry diagnostic tests for the cardiac market for early detection of heart attacks.
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.
This is a role well suited to an ambitious
professional, looking for the next step in their career. As a Senior Biochemist
for Technical Operations, you will be responsible for:
- Conducting validation and verification activities to ensure project completion within expected parameters and time frame.
- Designing and conducting experiments to identify process issues related to undesirable reagent or manufacturing performance, and identify resolutions for those issues.
- Planning, conducting, analyzing, and documenting experiments necessary to improve manufacturing process capability and reduce costs associated with cassette-based reagent production.
- Leading cross-functional manufacturing support team and mentoring junior biochemists.
- Collaborating with R&D personnel on product design changes and becoming a subject matter expert with respect to cardiac product reagent chemistry.
- Leading root-cause investigations and driving implementation of those solutions to improve reagent performance and manufacturability.
- Designing complex experiments, executing test protocols, and analyzing/interpreting their results.
- Applying principals of lean manufacturing and support continuous improvement activities to meet quality, cost and supply requirements.
- Effectively communicating (oral and written) work progress in both intra- and inter-departmental team forums.
- Providing well-written, coherent progress updates, validation documents, study protocols, and technical reports.
- Participating in supplier and internal audits; able to interact effectively with key suppliers.
This position may suit you best if you are familiar
with what is below, and would like to do develop your career with
- Systematic troubleshooting of complex reagent manufacturing formulations and processes both in individual and team-based projects.
- Writing and executing validation plans.
- Leading root-cause analysis efforts.
- Identifying and implementing process and/or equipment improvements.
- Planning and executing complex lab studies and utilizing specialized testing techniques.
- Analyzing, interpreting, and presenting complex data for review and summarizing results in a technical report.
- Complying with ISO and FDA requirements for the medical device industry.
Required skills to have for the success of this role
· Preferred Bachelors or Masters in Biochemistry or Chemistry.
· Min 5 years’ experience, preferably in a medical device or related industry
· Expertise and deep knowledge in protein chemistry
· Strength in one or more of the following areas: Clinical Chemistry, Immunoassays, Biostatistics, Manufacturing Process Capability, and Computer Science.
· Proven experience in successful root cause analysis and resolution of manufacturing or design issues.
· Demonstrated competence in experimental design and data interpretation
· Working knowledge of basic statistics necessary to develop sampling plans and analyze data.
· Able to prepare technical reports and testing protocols per approved department and site procedures.
· Must be well versed in Office Applications, particularly Excel and Access; experience in SAP or Minitab desired.
· Willing to do small amount of travel (<10%).
· Very organized, detail-oriented
· Highly self-motivated
· Able to work independently
· Excellent analytical, communication, writing, and problem-solving skills
· Effective and influential in his/her interactions in team-based assignments
· Able to work well with personnel from different departments, and experience levels
· Lean Manufacturing and CAPA Investigator experience
· Demonstrates good laboratory and manufacturing practices
· Working knowledge of manufacturing process performance trending
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Full / Part time: Full-time
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